FDA.reportPublic FDA data

CARDINORMA

Product NDC
59469-324
11-digit product format
594690324
Labeler code
59469
Product ID
59469-324_ee10404e-1016-4ab0-a62e-fa8c54a39f3b
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana Root, Activated Charcoal, Potassium carbonate, Lachesis Muta Venom, Nerium oleander Leaf, Tobacco Leaf, Peumus boldus Leaf, and SELENICEREUS GRANDIFLORUS WHOLE
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
ACTIVATED CHARCOAL; ARNICA MONTANA ROOT; LACHESIS MUTA VENOM; NERIUM OLEANDER LEAF; PEUMUS BOLDUS LEAF; POTASSIUM CARBONATE; SELENICEREUS GRANDIFLORUS WHOLE; TOBACCO LEAF
Active strength
8; 4; 8; 4; 4; 4; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARDINORMA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA ROOT4 [hp_X]/50mL
ACTIVATED CHARCOAL8 [hp_X]/50mL
POTASSIUM CARBONATE4 [hp_X]/50mL
LACHESIS MUTA VENOM8 [hp_X]/50mL
NERIUM OLEANDER LEAF4 [hp_X]/50mL
TOBACCO LEAF6 [hp_X]/50mL
PEUMUS BOLDUS LEAF4 [hp_X]/50mL
SELENICEREUS GRANDIFLORUS WHOLE4 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MUE8Y11327Internal UNII lookup
2P3VWU3H10Internal UNII lookup
BQN1B9B9HAInternal UNII lookup
VSW71SS07IInternal UNII lookup
7KV510R6H6Internal UNII lookup
6YR2608RSUInternal UNII lookup
Q4EWM09M3OInternal UNII lookup
X8H7HS7MRMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d84eabc6-c17b-41b9-a450-5ebc0752ca03Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-324-10CARDINORMA1 in 1 BOXSOLUTION/ DROPS12
59469-324-10CARDINORMA50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-324CARDINORMA (ARNICA MONTANA ROOT, ACTIVATED CHARCOAL, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, NERIUM OLEANDER LEAF, TOBACCO LEAF, PEUMUS BOLDUS LEAF, AND SELENICEREUS GRANDIFLORUS WHOLE) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_d84eabc6-c17b-41b9-a450-5ebc0752ca03.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARDINORMAARNICA MONTANA ROOT, ACTIVATED CHARCOAL, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, NERIUM OLEANDER LEAF, TOBACCO LEAF, PEUMUS BOLDUS LEAF, AND SELENICEREUS GRANDIFLORUS WHOLEPEKANA Naturheilmittel GmbHd84eabc6-c17b-41b9-a450-5ebc0752ca032023-01-11WarningsExact identifier
ndc (product): 59469-324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-324-10594690324101 BOTTLE, GLASS in 1 BOX (59469-324-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent